Analyte test strip and analyte meter device

Abstract

A test strip with an incorporated optical waveguide and deflectors punched through the optical waveguide allows light to exit through a layer of the test strip and be detected by a photo detector. Using light and a photodetector, these uniquely coded strips are identified. The waveguide can be constructed by sandwiching two layers of the test strip around a light transmissible layer. This configuration allows light to be transmitted through the test strip and out the other end, as well as allowing some light to escape the deflector. This light is detected by a photodetector mounted in the analyte test meter. The deflectors may be placed in patterns such that detection of this light indicates certain characteristics of the strip, such as non-counterfeit, regional identification, type of analyte tested, and coding information.

The invention claimed is: 
     
       1. A set of test strips comprising a plurality of test strips, each test strip comprising:
 (a) a top substrate; 
 (b) a bottom substrate; 
 (c) an electrical connector for connection to a meter disposed at a first end, wherein said electrical connector comprises a first tab formed at the first end of the top substrate, and a second tab formed at the first end of the bottom substrate, and wherein the first tab is not aligned with the second tab; 
 (d) an electrochemical test cell disposed toward a second end; and 
 (e) characteristic information encoded on the strip; 
 
       wherein:
 the plurality of test strips are arranged in a plurality of subgroups comprising a first subgroup and a second subgroup; and 
 a test strip arranged in the first subgroup is distinguishable from a test strip arranged in the second subgroup by a difference in dimension of the first tabs, the second tabs, or both the first tabs and the second tabs of the respective strips; and 
 the characteristic information is encoded on the test strip by the dimensions of the first tab, the second tab, or both the first tab and the second tab. 
 
     
     
       2. The set of test strips of  claim 1 , wherein:
 the second tab of the test strip in the first subgroup is not notched; and 
 the second tab of the test strip in the second subgroup is notched in a position selected from the group consisting of: in the middle of the tab, on the edge closest to the first tab, and on the edge farthest from the first tab. 
 
     
     
       3. The test strip of  claim 1 , wherein the characteristic information is selected from the group consisting of regional identification, calibration information, the type of analyte measured by the test strip, and alignment of the test strip. 
     
     
       4. A combination comprising (A) a test strip from the set of test strips of  claim 1  and (B) an analyte test meter, wherein the (B) analyte test meter comprises electrical connectors; circuitry for detecting electrical connectivity between the electrical connectors; and circuitry for correlating electrical connectivity between the electrical connectors with characteristic information encoded on the test strip. 
     
     
       5. The combination of  claim 4  wherein the characteristic information is selected from the group consisting of regional identification, calibration information, the type of analyte measured by the test strip, and alignment of the test strip within the apparatus. 
     
     
       6. The combination of  claim 4 , wherein the first end of the test strip is disposed in a strip port connector of the test meter. 
     
     
       7. The combination of  claim 4 , wherein an electrical connector of the meter is in contact with the first tab, the second tab, or both the first and second tab of the test strip. 
     
     
       8. A method for determining a characteristic of an electrochemical test strip comprising:
 (A) providing a test strip from the set of test strips of  claim 1 ; 
 (B) inserting the first end of the strip into an analyte test meter, said meter comprising strip port connector comprising electrical connectors; 
 (C) detecting electrical connectivity between the electrical connectors; and 
 (D) correlating electrical connectivity between the electrical connectors with characteristic information encoded on the test strip received within the meter. 
 
     
     
       9. The method of  claim 8  wherein the characteristic information is selected from the group consisting of regional identification, calibration information, the type of analyte measured by the test strip, and alignment of the test strip within the analyte test meter. 
     
     
       10. The method of  claim 8  wherein the meter has electronics to determine an amount of an analyte in a sample applied to the electrochemical test cell of the test strip. 
     
     
       11. The set of test strips of  claim 1 , wherein a test strip arranged in the first subgroup is identified as having a parent tab configuration and a test strip arranged in the second subgroup is identified as having a child tab configuration, wherein the first and/or second tabs of the test strip in the parent tab configuration have different dimensions than the first and/or second tabs of the test strip in the child tab configuration. 
     
     
       12. A set of test strips comprising a plurality of test strips, each test strip comprising:
 (a) a top substrate; 
 (b) a bottom substrate; 
 (c) an electrical connector for connection to a meter disposed at a first end, wherein said electrical connector comprises a first tab formed at the first end of the top substrate, and a second tab formed at the first end of the bottom substrate, and wherein the first tab is not aligned with the second tab; and 
 (d) an electrochemical test cell disposed toward a second end; 
 
       wherein:
 the plurality of test strips are arranged in plurality of subgroups comprising a first subgroup and a second subgroup; 
 a test strip arranged in the first subgroup is distinguishable from a test strip arranged in the second subgroup by a difference in dimension of the first tabs, the second tabs, or both the first tabs and the second tabs of the respective strips; 
 the second tab of the test strip in the first subgroup is not notched; and 
 the second tab of the test strip in the second subgroup is notched in a position selected from the group consisting of: in the middle of the tab, on the edge closest to the first tab, and on the edge farthest from the first tab. 
 
     
     
       13. A diagnostic test strip comprising:
 (a) a top substrate; 
 (b) a bottom substrate; 
 (c) an electrical connector for connection to a meter disposed at a first end, wherein said electrical connector comprises a first tab formed at the first end of the top substrate, and a second tab formed at the first end of the bottom substrate, and wherein the first tab is not aligned with the second tab; 
 (d) an electrochemical test cell disposed toward a second end; and 
 (e) characteristic information encoded on the strip; 
 
       wherein:
 the characteristic information is encoded on the test strip by the dimensions of the first tab, the second tab, or both the first tab and the second tab.